Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Respitrace Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
401 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854956 | RESPIGRAPH | Respitrace Corp. | 1986-03-20 | 99 | 0 |
| K852692 | RESPITRACE 300SC | Respitrace Corp. | 1985-07-15 | 19 | 0 |
| K823780 | RESPITRACE 300SC | Respitrace Corp. | 1984-01-20 | 401 | 0 |
| K823783 | RESPICOMB | Respitrace Corp. | 1984-01-11 | 392 | 0 |
| K823782 | RESPITRACE SYSTEM | Respitrace Corp. | 1983-03-07 | 82 | 0 |
| K772016 | RESPITRACE | Respitrace Corp. | 1978-01-26 | 93 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda